Our growth journey continued in the third quarter, strengthening our Haematology franchise with the announcements of the intention to acquire Dova Pharmaceuticals1and our decision to opt in early to the development of BIVV001. Revenue growth in the quarter was 27 per cent with revenue of SEK 2,930 M (2,315). EBITA was SEK 1,099 M, resulting in an EBITA margin of 38 per cent
The cadence of upcoming launches and approvals across indications and regions that Doptelet provides, enables us to further accelerate growth in our haematology franchise
Our strong performance continued in the second quarter, with organic growth of 25 per cent taking us to revenue of SEK 3,163 M, adjusted EBITA of SEK 1,193 M and an adjusted EBITA margin of 38 per cent. Announcing the acquisition of emapalumab and related assets, we took further steps to sharpen focus on our core therapeutic areas and on late-stage assets
We are proud to support Investigator-Sponsored Studies because the research conducted by the community adds substantially to an increased understanding of pre-clinical and clinical value of haemophilia treatment
This data supports the observation that the introduction of EHLs has allowed for people with haemophilia to live a life beyond haemophilia, with increased quality of life and a greater ability to engage in sports and activities
Development of inhibitors continues to be a significant challenge for people with haemophilia and it remains an area of unmet need
Sobi is committed to liberating life for people with haemophilia. These results suggest that even in a country such as Sweden, with well-established use of prophylactic treatment and high levels of access to treatment, there is a need for further research to address knowledge gaps and enable people to live a life beyond haemophilia
By increasing the scientific evidence and the understanding of the clinical value of our extended half-life products in all patient groups living with haemophilia, we maintain our focus on research and an approach to treatment that reflects a meaningful difference for patients, allowing them to live a life beyond haemophilia
It is extremely encouraging to see a complete response in the first six patients treated with emapalumab, particularly considering that MAS is a serious and potentially fatal complication, and that all of these patients had failed other treatments
Sobi’s position is stronger than ever and I see ample opportunity to take Sobi to the next level.
It is of great importance to offer an individualised prophylactic treatment to reduce the need for and occurrence of surgery as well as an optimal and measurable factor treatment during surgery.
“We started 2019 with a strong first quarter, with revenues of SEK 3,265 M and EBITA of SEK 1,509 M, corresponding to an EBITA margin of 46 per cent. We completed the acquisition of Synagis in late January and are in the process of integrating Synagis operations and employees into the organisation. The Haemophilia franchise continued to grow strongly, we have seen positive effects from the Gamifant launch in the US even though it is still in early launch phase, and we see an increasing demand for Synagis.”
2018 was a year of transformation for Sobi. Our substantial progress in Haemophilia, acquisitions in Immunology and sales growth in Specialty Care mean that the company is essentially, on a pro-forma basis, two-and-a-half times the size it was at the end of 2016. But it is important to understand that we see this as an important stepping stone. In the Annual and Sustainability Report, we outline how the strong growth we delivered throughout 2018 is fuelling our vision of becoming global leaders in providing innovative treatments that transform life for people with rare diseases
“Liberate Life not only spells out our vision for the future of haemophilia care but also serves as a call to action for involvement from patients, advocates and healthcare professionals.”
We are honoured to be recognised by NORD for the work we have done to bring Gamifant to primary HLH patients. Primary HLH is often fatal, and we are grateful to be able to contribute to helping these very sick patients.
In this study, the majority of these very sick patients who were treated with emapalumab were able to reach transplant, engraft and survive
2018 was a significant year for Sobi. Revenues grew 40 per cent, totalling SEK 9,139 M (6,511) for the full year. We generated operating leverage and grew earnings by 74 per cent, with EBITA of SEK 3,571 M (2,053). Gross margin rose to 74 per cent (72).
“This new expanded indication allows all patients access to treatment, which is particularly significant as the disease often presents in newborns,” says Norbert Oppitz, Head of Specialty Care at Sobi. “Following stabilisation with acute intravenous therapy, children can now be managed long-term on Ravicti in the early days of their lives.”
We are very encouraged by the data being presented at ASH on emapalumab in primary HLH, and we look forward to investigating emapalumab in additional diseases for which interferon gamma is considered pathogenic
Joint protection remains a significant challenge in the long-term treatment of haemophilia keeping individuals from living a life without constraints of their disease and these results confirm that our therapies can play a role in the effective prevention of joint bleeds
We are thrilled that the clinical data on emapalumab in primary HLH has been selected for presentation at this important medical congress. We appreciate this recognition from ASH as it confirms the relevance of the underlying science to further the understanding of HLH, and the spotlight this shines on a very rare life-threathening disease. This would not have been possible without the support of the study investigators and participanting patients over a number of years
The FDA approval of Gamifant marks an important milestone in Sobi’s vision to bring transformative treatments to patients with a high medical need,
As the largest Sweden-based pharmaceutical company listed on Nasdaq Stockholm, our growth in the European financial market has been substantial over the past years. Paula has an excellent network and knowledge of the field and we look forward to expand and further develop our relations with investors and the financial community under her leadership
I am excited about adding Synagis to our portfolio as it remains the only product preventing RSV infection in this vulnerable patient group with a great medical need. The addition of Synagis will become an important strategic catalyst for Sobi’s future development and will form a powerful platform for growth in rare diseases.
The strong growth continued during the quarter.
Sobi has unique capabilities, a heritage in biologics manufacturing, development and supply, and a very exciting future within the rare disease space. I look forward to working with the teams to develop an effective and agile organisation set for growth.
I am very pleased that we were able to enrol the first patient in this important study. We look forward to learning more about how SOBI003 may potentially be able to help patients in the future as we enrol more patients into the study,
We believe this transaction is an excellent fit for Sobi and consistent with our strategy of expanding our commercial Specialty Care portfolio, stengthening our business in the US.
We see transparency as an integral part of our business, and the EFPIA Disclosure Code is an important mechanism for ensuring long-term trust for and within our industry. Dialogue and interaction between healthcare professionals and organisations is essential in building sustainable value for rare disease patients and rare disease communities around the world. Our commitment to transparency ensures that we meet the high standards for integrity that patients, prescribers, budget holders, other stakeholders and we ourselves expect
By gathering data on outcomes such as physical activity and joint health status, we maintain our focus on research that reflects a meaningful difference for patients, providing protection beyond bleed prevention. The real-world data generated thus far support the safety profile of our products. Since both products are indicated for all age groups, in prophylaxis, on-demand as well as in surgery, they also provide the opportunity for individualised treatment.
2017 was a great year and 2018 is off to a strong start, with total revenue growth of 41 per cent, leading to revenues of SEK 1,964 M for the quarter. Elocta and Alprolix® continued to deliver impressive results in Haemophilia, and both Kineret and Orfadin® showed solid growth in Specialty Care. The FDA accepted an Investigational New Drug (IND) application for SOBI003 and granted Fast Track status. Kineret received a positive opinion for the treatment of Still’s disease in the EU, followed by the European Commission (EC) approval after the end of the quarter.
With this new indication, patients with Still’s disease will get access to an alternative treatment with an established safety profile
His experience from the pharmaceutical industry, numerous company integrations and the global roles he has held will be of great value for Sobi, supporting our organisation and our journey to become a global leader in rare dise
Sustainability is a vital part of our vision and overall corporate strategy. A sustainable business entails a commitment to responsibility for patients and employees, reduced environmental impact from operations and treatment, as well as long-term sustainable profitability so that we can continue to reinvest in developing new therapies for rare diseases and serve our communities for many years to come
It is a pleasure to welcome Henrik to Sobi. His experience from the pharmaceutical industry and specifically from acquisitions and deal making in specialty pharma will be of immense value for Sobi on our journey to become a global leader in rare diseases and specialty care
We are very pleased with the CHMP positive opinion which recommends including this indication for Kineret in the EU. Sobi is committed to improving the lives of people affected by rare diseases, and this recommendation, if approved by the European Commission, would help address an unmet medical need for people with Still’s disease
“2017 was an outstanding year for Sobi. We delivered and exceeded expectations. Our Haemophilia franchise continues to grow rapidly. During the year, we established our new business area Specialty Care which we expect to be a strong contributor to future growth. We also made advancements in our pipeline portfolio, initiating several clinical studies.”
“With the outcome of the adjudication of both of these tenders, Sobi has demonstrated our desire to provide access to these innovative products in a very sustainable manner.”
We are very pleased with the IND acceptance and Fast Track status granted by the FDA. It is an important step towards initiating the first clinical study with SOBI003 in children affected by MPS IIIA. The Fast Track status granted by the FDA is a milestone and acknowledgement of the significant unmet medical need that SOBI003 may be fulfilling
In collaboration with Bioverativ, we will continue to explore the potential of Alprolix to reduce the burden of disease and create meaningful improvement in the lives of people living with haemophilia
Together with Bioverativ, we have long been committed to transforming the care of people with haemophilia through our treatments and ongoing research
The introduction of new nitisinone dosing options, such as Orfadin oral suspension, is the result of Sobi listening to feedback from patients and caregivers and continuing to innovate to meet their needs
We are very pleased with having initiated this confirmatory clinical study investigating the safety and efficacy of anakinra in people with Still’s disease. This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need
Krassimir Mitchev, MD, PhD, Vice President and Medical Therapeutic Area Head of Haemophilia at Sobi
A strong business performance was shown across the portfolio in the third quarter, with the main contributors being Elocta and Alprolix. Elocta sales increased more than 600 per cent compared to the same period last year and Alprolix sales increased with approximately 500 per cent. This strong growth momentum encourages us to be confident around the prospects of our Haemophilia franchise.
We are delighted that Norbert could join Sobi. Norbert is a true entrepreneur, and his experience will be instrumental in realising our ambitions to bring Sobi to the next level as we look for external growth opportunities for our Specialty Care business
We are very happy to receive the approval by the FDA of the new dosing frequency for Orfadin. Orfadin is the first nitisinone product approved for once daily use in the US This is an important step towards reducing the treatment burden of people with HT-1 and it follows Sobi’s introduction of Orfadin 20mg capsules and Orfadin oral suspension
New data will reinforce that Elocta and Alprolix treatment can maintain low ABRs, therefore helping improve the long-term quality-of-life for people with haemophilia A and B
We are very pleased with the orphan drug designation from the FDA for SOBI003. MPS IIIA is a severe and debilitating disease, and this development program is an important part of our mission of being pioneers in rare diseases. We are currently in the late pre-clinical phase and expect to initiate the first clinical trial with SOBI003 in 2018